AB1323 ANALYSIS OF ADVERSE EFFECTS AFTER VACCINATION AGAINST COVID-19 IN PATIENTS WITH IMMUNO-MEDIATED RHEUMATIC DISEASES IN MANAUS – AMAZONAS
Authors: M. M. Sousa Dias, N. Seixas de Melo, S. E. B. Dias, C. Pinheiro Martins, V. Miki Pang Takatani, R. Beatriz Nazareth Alagia, B. Guimarães Dutra, G. Bacellar Marques, D. Queiroz Rego, D. Buzaglo Gonçalves, C. Telles, S. Ribeiro
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> Immune-Mediated Rheumatic Diseases (IMRD) are characterized by a chronic inflammatory response, have several clinical manifestations and are more susceptible to infections and worse prognosis. Thus, in the context of the COVID-19 pandemic, to reduce morbidity-mortality, vaccination is an effective method of prevention. However, there are not enough studies that encompass this group of patients, leaving many doubts about the adverse effects and its safety and effectiveness. <h3>Objectives</h3> Analyze the adverse effects observed in patients with IMRD after vaccination against COVID-19. <h3>Methods</h3> Observational, longitudinal, ambidirectional research, with follow-up of groups of patients with IMRD immunized with vaccines made available by the Programa Nacional de Vacinação with Coronavac (Instituto Butantan), AstraZeneca (BioManguinhos/Fiocruz), Pfizer/BioNTech and Janssen (Johnson &amp; Johnson). Sociodemographic data and data on the adverse effects presented were collected, recorded through a diary delivered to each patient, filed on an online platform. This study was approved by the local Ethics and Research Committee. <h3>Results</h3> 223 patients over 18 years of age were included, the mean age is 42.79±15, 83% women. The main DRIM: Systemic Lupus Erythematosus (39%) and Rheumatoid Arthritis (33.6%). In the 1st dose, 78.3% of the vaccines applied were Coronavac, 18.9% AstraZeneca and 2.8% Pfizer/BioNTech, the adverse effects found were: Pain at the injection site (49.3%), Headache (43.3%), Tiredness (34.3%) and Nausea (21.6%). In the 2nd dose, with the same vaccines applied as the previous dose, the adverse effects: Pain at the injection site (44.6%), Headache (33.9%), Tiredness and Vertigo (21.5%). In the 3rd dose, 55.3% of AstraZeneca, 44.2% of Pfizer and 0.4% of Janssen, in relation to adverse effects: Pain at the injection site (65.2%), Headache (41.8%), Tiredness (36.2%) and Edema and hardening of the skin at the injection site (31.9%). For the 4th dose, the AstraZeneca (14.9%) and Pfizer (85.1%) vaccines were applied, the adverse effects found: Pain at the injection site (58.5%), Hardening of the skin at the injection site injection (24.4%), Headache (19.5%), Tiredness (17.1%). <h3>Conclusion</h3> It is observed that the adverse effects presented after each administered dose are mild to moderate, more frequent: pain at the injection site and headache without significant differences compared to the general adult population. <h3>References</h3> [1]Cecconi, M., et al., Incidence of Infectious Adverse Events in Patients With Rheumatoid Arthritis and Spondyloarthritis on Biologic Drugs-Data From the Brazilian Registry for Biologics Monitoring. J Clin Rheumatol, 2018. [2]Ministério da Saúde. Manual de vigilância epidemiológica de eventos adversos pós-vacinação, 2014. [3]Petri M, et al. Lupus International Collaborating Clinics classification criteria for systemic lupus erythematosus. Arthritis Rheum.64(8):2677-86Aug, 2012. [4]Serrano, E. V et al. Transcultural adaptation of the "EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI)" into Brazilian Portuguese. Revista Brasileira de Reumatologia, v. 53, n. 6, p. 483-493, 2013. [5]Shiboski, C. H. et al. 2016 American College of Rheumatology/European League Against Rheumatism Classification Criteria for Primary Sjögren's Syndrome: a consensus and data- driven methodology involving three international patient cohorts. Arthritis and Rheumatology, v. 69, n. 1, p. 35-45, 2017. <h3>Acknowledgements:</h3> NIL. <h3>Disclosure of Interests</h3> None Declared.